By Diagnostic World Staff
November 21, 2024 | Illumina announced an expansion of its TruSight Oncology portfolio this week at the annual meeting of the Association of Molecular Pathology (AMP) in Vancouver, British Columbia, with TruSight Oncology 500 v2 planned for global release in mid-2025.
TSO 500 v2, Illumina’s flagship cancer research assay to enable comprehensive genomic profiling (CGP), assesses hundreds of genes across all variant classes, and immuno-oncology biomarkers, in a single assay from one sample, to facilitate therapy selection research. CGP is a critical tool for identifying actionable alterations, including rare mutations, which enables precision medicine in accordance with professional guidelines, Illumina believes.
Key features to TSO 500 v2 include faster turnaround time and reduced hands-on time; sensitive variant calling and improved coverage of difficult genomic regions; and gold-standard Myriad Genomic Instability Score (GIS) to determine homologous recombination deficiency (HRD) status for all samples.
TSO 500 v2 also will have new kit configurations with 50% less packaging, 70% fewer tubes, and improved usability and will offer automation methods with flexible batch sizes.
Users can enjoy integrated and automated data analysis, from sequencer to insights supported with DRAGEN secondary analysis and Illumina Connected Insights, or Velsera’s Clinical Genomics Workspace (CGW). Early users report the assay’s applications for clinical research in identifying rare genetic biomarkers and fusion biomarkers.
“We are excited to assess the new features of the TruSight Oncology 500 v2 tissue assay, such as the faster workflow, improved coverage, and lower DNA/RNA input levels,” said early user Wei Song, MD, PhD, director of Clinical Genomics and Molecular Pathology at the University of California, San Diego in a statement. “Such improvements are highly relevant to clinical research laboratories and can positively affect time to results, quality of results, and the processing of challenging tissue samples.”
Illumina's oncology portfolio has evolved over time to fit customers' diverse needs for versatility and scalability. The TSO portfolio encompasses research-use-only (TSO 500 products) and in-vitro diagnostic (TSO Comprehensive) solutions across a range of low-, mid-, and high-throughput instrumentation. Illumina also announced today that TSO Comprehensive kits are now available to ship. In August, the company announced FDA approval of its TSO Comprehensive test and its first two companion diagnostic indications.
“In listening to our broad range of customers, we understand there are different needs for biomarker profiling, and Illumina has successfully introduced a continuum of solutions to address varying levels of need,” said Traci Pawlowski, vice president of Clinical Solutions at Illumina in a statement.